Lauric acid [dodecanoic acid]
The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re‐evaluated lauric acid, considering all toxicity endpoints.
In an oral 18‐week study no substance‐related effects were observed in rats up to 9000 mg/kg body weight and day. As lauric acid is an organic acid, the respiratory tract might be a target organ; however, inhalation studies are not available. A maximum concentration at the workplace (MAK value) was derived by read across to other solid acids. Lauric acid is irritating to the rabbit eye but less so than succinic and adipic acid. Also the acidity of saturated solutions of lauric acid is less than that of succinic and adipic acid. For the latter acids, a MAK value of 2 mg/m3 for the inhalable fraction was set like that for phosphoric acid. Phosphoric acid is a stronger acid that is corrosive to the eyes of rabbits. Therefore, in analogy to phosphoric acid as a worst‐case, a MAK value of 2 mg/m3 for the inhalable fraction is set for lauric acid.
As the MAK value has been derived in analogy to phosphoric acid, lauric acid is also classified in Peak Limitation Category I with an excursion factor of 2.
Lauric acid does not have genotoxic potential. There are no carcinogenicity studies available with lauric acid. Results of a dermal initiation‐promotion study with lauric acid alone were negative; promoting activity was seen only after application of an initiator. Lauric acid is no longer classified as carcinogenic to humans, based on the Commission's evaluation of this type of study.
No significant contribution to systemic toxicity was demonstrated in calculations of dermal absorption. Limited data in animals do not indicate a sensitizing potential for lauric acid.
Developmental toxicity studies are lacking; therefore, lauric acid is assigned to Pregnancy Risk Group D.